Acronym

TOPCAT-G

Study hypothesis

The primary aim of the current study is to conduct a randomised, feasibility trial comparing new nurse-led follow-up with standard, hospital-based, medical follow-up. The study will determine the feasibility and acceptability of a new nurse-led approach. Feasibility will be determined by assessing the number of patients eligible to be included in the study, monitoring recruitment and retention rates, and exploring the willingness of participants to be randomised and to complete outcome measures relating to quality of life, health economics, well-being, relapse and survival.

Study design

Primary study design

Secondary study design

Trial setting

Other

Trial type

Quality of life

Patient information sheet

See additional files (participant information sheets available in English and Welsh)

Condition

Gynaecological cancer

Intervention

1. Standard care:Patients randomised to standard care will continue to have their usual hospital-based doctor-led medical reviews (at 6, and 9 months post-treatment), and will complete the Macmillan Concerns Checklist prior to their 6- and 9-month follow-up appointments at the clinic and this will inform the discussion with the clinician. Following consent, but prior to randomisation, patients will be asked to complete a set of study outcome questionnaires at baseline (at the routine 3-month follow-up appointment). Patients will also be asked to complete the study outcome questionnaires after their 6 and 9 month follow-up appointments.

2. Nurse-led intervention:The intervention group patients will not attend the hospital for their usual follow-up appointments but will receive a nurse-led telephone follow-up intervention, known as Optimal Personalised Care After Treatment for Gynaecological cancer (OPCAT-G). After patients have been allocated to the nurse-led intervention arm of the study, patients will be introduced to the Clinical Nurse Specialist (CNS) who will deliver the intervention. The CNS will give the patients an information booklet which will include information on patterns of relapse, possible warning symptoms, and how to respond to these. Information will also be given on possible long-term physical and psychological side-effects of treatment and how they can contact the clinical team if they have concerns or symptoms. Patients will receive treatment and diagnosis-specific supplementary leaflets attached to the booklet. The CNS will also give patients a set of needs assessment measures, including:1. Macmillan Concerns Checklist. This checklist addresses 23 physical concerns, 9 practical concerns; 3 family/relationship concerns; 9 emotional concerns; 3 spiritual or religious concerns, and 9 lifestyle or information needs. Patients are asked to tick a box for any problems that have caused concern during the previous week.2. CancerCAN22. This is a multi-domain needs assessment tool that measures unmet needs across 22 items (12 psycho-social needs items and 10 treatment and care items). 3. Distress Thermometer. This is a reliable measure of patients’ distress and concerns.Patients will be asked to complete the needs assessment measures prior to a scheduled telephone call from the CNS. The scheduled telephone call will take place within four weeks of randomisation and will involve a structured interview with the CNS. Patients will be asked about their general well-being and about any gynaecological symptoms experienced. Any identified needs or concerns from the three needs assessment measures will be discussed. Patients in whom problems or unmet needs are identified will be evaluated and directed to the most appropriate source of help. This could include a patient self-help group, their general practitioner, or hospital review by the gynaecology, oncology or clinical psychology team. Patients will receive additional copies of the needs assessment measures by post and will be told that if they have any problems between telephone calls, they should complete their assessments and contact the CNS. Patients will be encouraged to report problems promptly with these concerns addressed in the same structured way. Patients will then receive another scheduled telephone call at 9 months post-treatment. Patients will also receive the three needs assessment measures by post and will be asked to complete them one week prior to their 9-month scheduled telephone call from the nurse. The telephone contact will again include a structured interview and any identified needs or concerns will be discussed following the same structure as the first telephone call interview. In addition to the nurse-led intervention, patients will be asked to complete the same study outcome questionnaires as patients in the standard care arm. The outcome questionnaires will be completed at baseline (prior to randomisation) and again at 6 months post-treatment and following the 9-month telephone follow-up.

Intervention type

Other

Phase

Drug names

Primary outcome measures

1. Patient recruitment rate. This will be calculated from the total number of patients invited to take part in the study and the number of patients giving written consent to participate in the study2. Patient attrition rate. This will be calculated from the number of patients who gave written consent and the number of patients who have completed any measures, regardless of their completion rate

Secondary outcome measures

A set of study outcome questionnaires will be administered at baseline and at 6 and 9-months post-treatment: 1. EORTC QLQ-C30. This is a validated measure to assess the quality of life of cancer patients2. EQ-5D-3L. This is a validated generic, health-related, preference-based measure comprising five domains: mobility; self-care; usual activities; pain and discomfort; anxiety and depression3. ICECAP-A (ICEpop CAPability measure for Adults) is a measure of capability for the general adult population4. Client Service Receipt Inventory. This is a measure of self-report service user to evaluate and cost service useAdditional data to be captured will include:5. Patient demographics, cancer type and stage, type of treatment received and comorbidity at baseline6. Data on the pattern, timing and method of detection of relapse and on survival from patient records and routinely captured data sources

Overall trial start date

01/05/2015

Overall trial end date

31/12/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Female patients who have completed treatment for cervical, endometrial, epithelial ovarian, or vulvar cancer within the last 3 months in BCUHB in North Wales2. Patients who have completed treatment for fallopian tube and primary peritoneal carcinoma3. Patients will be included if they are considered fit for taking part in the trial and able to give informed consent, as assessed by the multi disciplinary team4. Patients may have received surgery, chemotherapy, radiotherapy or a combination of these but will not be receiving any continuing treatment that requires hospital care5. At the time of entry, patients in the view of their treating consultant will not have a definite need for continued hospital care

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

50

Participant exclusion criteria

1. Patients having had treatment for sarcoma, germ cell tumour, borderline tumours or choriocarcinoma will be excluded as these women tend to require specific and/or more intense follow up often with serial imaging or tumour markers2. Patients requiring ongoing treatment3. The study will not include patients who do not have capacity to give informed consent or who are deemed to be unable to take part in the trial (e.g., severe learning/mental disability, severe mental health problems)4. Patients who are not able to understand Welsh or English

Recruitment start date

01/07/2015

Recruitment end date

31/12/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Betsi Cadwaladr University Health Board
-
United Kingdom

Sponsor information

Organisation

Betsi Cadwaladr University Health Board

Sponsor details

Mountain View Penrhos Road Bangor LL57 2NA United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

University/education

Funder name

Betsi Cadwaladr University Health Board

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

1. Results from this study will be presented via posters and oral presentations at regional and national meetings where interested doctors, specialist nurses and health service managers would be present. This would include specialist meetings relating to Gynaecological Oncology, Medical Oncology, Health Psychology/Psycho-Oncology and Health Economics 2. Papers will be submitted to relevant international journals such as International Journal of Gynecological Oncology, British Journal of Obstetrics and Gynaecology, Lancet Oncology and British Journal of Cancer. The results would be distributed to policy makers, advisory groups and professional bodies, for example the Welsh Government, the National Strategic Advisory Group (NSAG), Gynaecological Cancer National Specialist Advisory Group, the National Cancer Information Network and NICE. We would also communicate the key results to patient support groups such as Ovacome, Jo’s Cervical Cancer Trust, Macmillan Cancer Support and Tenovus.3. Preparation of the protocol for a national randomised, multicentre trial comparing OPCAT-G with standard care would be a key output from this work. Four publications are also expected from the work of the Tenovus PhD student and these will include data derived from the proposed study.